New European Union GMO regulations come into force.

E.U. regulations have come into force that require full traceability and labeling of GMOs throughout the chain from farm to table
New European Union GMO regulations come into force.
April 27, 2004

E.U. regulations have come into force that require full traceability of GMOs throughout the chain from farm to table and to provide comprehensive information for consumers by labeling all food and feed consisting of, containing or produced from a GMO.

Health and Consumer Protection Commissioner David Byrne said the E.U. now has the most rigorous pre-marketing assessment of GM food and feed in the world. "Consumers will also have a clear choice of products to buy as GM food will now be clearly labeled," Byrne said. "For the first time, farmers will see labels on GM feed. Europe will now have a comprehensive and transparent system of authorization and labeling that can only enhance business and consumer confidence."

According to an E.U. survey, 70% of Europe's public does not want GM food, and 94% want to be able to choose whether or not they eat it. But for U.S. food manufacturers, the new regulation appears as nothing more than another barrier from a continent that has consistently made it difficult for any food products containing genetically modified ingredients to reach its shelves.

"These new requirements establish a serious trade barrier that will keep many food products out of the European market," said John Cady, president and chief executive of the U.S. National Food Processors Association, which urged the World Trade Organization to address the E.U.'s new rules.

"European consumers will see such labels on food products as 'warning labels.'
"However, there is no safety or nutrition issue associated with the products of agricultural biotechnology on the market, and there is no scientific basis for requiring the labeling of biotech foods."

Cady called the traceability requirements "a classic case of regulatory overkill, putting complex and detailed new requirements on food companies, with no benefit but with added expense for consumers."

The regulation requires business operators when using or handling GM products to transmit and retain information at each stage of marketing. Information concerning the presence of GMOs in products must be transmitted throughout the commercial chain and must be retained for five years.

The label must indicate "This product contains genetically modified organisms" or "... produced from genetically modified (name of organism)".

The regulation  introduces for the first time comprehensive labeling requirements of GM feed based on the same principles as those for GM food. The regulation requires labeling of ingredients, such as corn gluten feed produced from GM maize or GM soybean meal and any compound feed that includes such ingredients.

Under previous legislation, the presence of GM material in conventional food did not have to be labeled if it was below 1% and if it could be shown to be adventitious and technically unavoidable. The Parliament confirmed in its new rules a threshold of no higher than 0.9%.
Under previous legislation, there was no tolerance threshold for the adventitious presence of GM material in food or feed which had not been authorized but which had received a favorable E.U. scientific risk assessment. The new rules contain a 0.5% threshold for the adventitious or technically unavoidable presence of such GM material, provided that the operator can demonstrate that its presence was technically unavoidable. A product will not be allowed on the market if it exceed this threshold.
This provision will expire after three years.

The regulation also provides that GMOs that could be used as food or feed must be authorized for both uses or not at all. The regulation establishes a "one door, one key" procedure for the scientific assessment and authorization of GMOs and GM food and feed resulting in a centralized, E.U. procedure where an operator is able to file a single application. The scientific risk assessment will be carried out by the European Food Safety Authority, whose opinions will be made available to the public, which will have the opportunity to comment.

On the basis of this opinion, the Commission will draft a proposal for granting or refusing authorization. The proposal will be approved through qualified majority by the member states within a Regulatory Committee. Authorized products will be entered into a public register of GM food and feed. The authorization will be granted for a period of 10 years, subject to a post-market monitoring plan, and will be renewable for 10-year periods.
Existing GM products also will be entered into the public register, with the 10-year time limit beginning from the day when the product was first placed on the market.

The simplified approval procedure for GM foods that are considered to be substantially equivalent to existing foods will be abandoned. Current GM products will remain eligible for marketing, but operators are required to provide detection methods to the Commission within six months of the new law's entry into force.